Trial Outcomes & Findings for Study of the Effectiveness of Green Diode Laser Light on Body Shaping (NCT NCT01292538)
NCT ID: NCT01292538
Last Updated: 2020-02-10
Results Overview
Mean change in total combined circumference inches of the waist, hips and bilateral thighs from baseline to endpoint evaluation.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
67 participants
Primary outcome timeframe
2 weeks
Results posted on
2020-02-10
Participant Flow
Participant milestones
| Measure |
Erchonia GLS 532nm
532nm green laser light therapy.
Erchonia GLS: 532 nm green diode low level laser light device
|
Placebo Laser
Sham light output with no therapeutic benefit
Placebo laser: Sham light output with no therapeutic benefit
|
|---|---|---|
|
Overall Study
STARTED
|
35
|
32
|
|
Overall Study
COMPLETED
|
35
|
32
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Study of the Effectiveness of Green Diode Laser Light on Body Shaping
Baseline characteristics by cohort
| Measure |
Erchonia GLS 532nm
n=35 Participants
532nm green laser light therapy.
Erchonia GLS: 532 nm green diode low level laser light device
|
Placebo Laser
n=32 Participants
Sham light output with no therapeutic benefit
Placebo laser: Sham light output with no therapeutic benefit
|
Total
n=67 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
36.60 years
STANDARD_DEVIATION 10.05 • n=5 Participants
|
39.03 years
STANDARD_DEVIATION 10.16 • n=7 Participants
|
38.04 years
STANDARD_DEVIATION 10.08 • n=5 Participants
|
|
Sex: Female, Male
Female
|
28 Participants
n=5 Participants
|
25 Participants
n=7 Participants
|
53 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
29 Participants
n=5 Participants
|
32 Participants
n=7 Participants
|
61 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
6 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 2 weeksMean change in total combined circumference inches of the waist, hips and bilateral thighs from baseline to endpoint evaluation.
Outcome measures
| Measure |
Erchonia GLS 532nm
n=35 Participants
532nm green laser light therapy.
Erchonia GLS: 532 nm green diode low level laser light device
|
Placebo Laser
n=32 Participants
Sham light output with no therapeutic benefit
Placebo laser: Sham light output with no therapeutic benefit
|
|---|---|---|
|
Combined Circumference in Inches of the Waist, Hips and Bilateral Thighs
|
-3.895 inches
Standard Deviation 3.03
|
-1.136 inches
Standard Deviation 2.27
|
Adverse Events
Erchonia GLS 532nm
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Placebo Laser
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place